MAUDE Adverse Event Report: RICHARD WOLF GMBH; FLEX. GRASP. FORCEPS 6.6FR WL 550MM

Model Number	8736685
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/20/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Flex.Grasp.Forceps 6.6fr wl 550mm, part id: 8736.685, was produced on march 22, 2021 with the lot number 4500330894.The batch size was 13 units.There have been 2 complaints related to this batch number with a similar issue since then and including this case.The user facility stated that the instrument with this lot number has been utilized approximately 20 splint removals in the past 2 years and 3 months.
Event or Problem Description
The user facility has informed richard wolf gmbh (rwgmbh) of an issue regarding an flex.Grasp.Forceps 6.6fr wl 550mm, part id: 8736.685, lot # 4500330894.According to the received information, a procedure to remove the ureteral stent was planned using the surgical instrument."after insertion into the working channel, the forceps were opened to grip the splint.When gripping/closing, the jaws blocked.Forceps did not close.After actuating the gripping device several times, the forceps finally closed.We removed the forceps and aborted the procedure to prevent it from blocking again.The instrument was checked for integrity before sterilization.Also immediately before use on the patient.It then failed during the procedure." there is no report of injury to the patient or other personnel.However, the reported issue caused a 10 minute delay and the scheduled procedure was not completed.

• Common Device Name: FLEX. GRASP. FORCEPS 6.6FR WL 550MM
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: valentin felsing ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 18364762
• Report Number: 9611102-2023-00074
• Device Sequence Number: 7912679
• Product Code: FCL
• UDI-Device Identifier: 04055207020289
• UDI-Public: 04055207020289
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 8736685
• Device Catalogue Number: 8736.685
• Device Lot Number: 4500330894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2023
• Initial Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/22/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown